FDA official hopeful younger kids can get shots this year

OCH administered COVID vaccines and COVID boosters on August 13, 2021.

The Food and Drug Administration’s vaccine chief is pledging to rapidly evaluate COVID-19 vaccines for younger kids — as soon as the studies are in.

Posted: Sep 10, 2021 4:51 PM

The Food and Drug Administration’s vaccine chief said Friday the agency will rapidly evaluate COVID-19 vaccinations for younger children as soon as it gets the needed data — and won't cut corners.

Dr. Peter Marks told The Associated Press he is “very, very hopeful” that vaccinations for 5- to 11-year-olds will be underway by year’s end. Maybe sooner: One company, Pfizer, is expected to turn over its study results by the end of September, and Marks say the agency hopefully could analyze them “in a matter of weeks.”

In the U.S., anyone 12 and older is eligible for COVID-19 vaccines. But with schools reopening and the delta variant causing more infections among kids, many parents are anxiously wondering when younger children can get the shots.

Pfizer’s German partner BioNTech told weekly Der Spiegel Friday that it was on track “in the coming weeks” to seek approval of the companies' COVID-19 vaccine for 5- to 11-year-olds. Moderna, which makes a second U.S. vaccine, told investors this week to expect its data on that age group by year’s end. Both companies also are testing their vaccines down to age 6 months, but those results will come later.

FDA’s Marks spoke with the AP Friday about the steps involved in clearing pediatric vaccines. The conversation has been edited for clarity and length.

Q: Many parents had hoped for vaccines for children under 12 by the time schools reopened. Why is it taking so long?

A: Before you can actually approve something in an age range, you actually have to study in that age range. ... Children under the age of 12, they’re not little adults, they’re not. And so one does actually have to study this and even change perhaps the dose that’s being given — and in fact, that’s had to happen, change the dose.

We have to then be able to look at the data at FDA when it gets submitted to us. We’ll look at it very rapidly and feel confident that when we that we’ve looked through the data that these are going to be safe and effective and that we can reassure parents that the benefits of their child getting one of these vaccines certainly outweighs any risks.

Q: The American Academy of Pediatrics cited delta's growing threat to children in urging a faster decision, after FDA requested expanded child studies. Why does FDA want that extra data?

A: I’m not sure that there’s much disagreement. We clearly want to see children in the age range 5 to 11 vaccinated as soon as possible. But the difference between the smaller dataset and the larger dataset is not very much in terms of time, because there were enough willing participants here — parents who were very interested in having their 5- to 11-year-olds vaccinated — that it didn’t take that much longer.

We’ll be able to give people I think a much better sense that these vaccines are indeed safe and effective for their children.

Q: Could 5- to 11-year-olds be vaccinated by the end of the year?

A: I am very hopeful in that regard. Very, very hopeful in that regard.

Q: How fast can FDA act once the companies submit their data?

A: Pfizer made a public statement that they intended to give us their data by the end of September. ... We’re going to do a thorough job on that as quickly as we can so that at the end of the day, hopefully within a matter of weeks rather than a matter of months, we’ll be able to come to some conclusion -- again, barring some finding that we’re not expecting.

Q: How will the trials show effectiveness for kids?

A: In the 12- to 15-year-olds, we saw an immune response that was actually as good or better — in this case, it was for the Pfizer vaccine — it was actually better than in 16 and up. And so we’d want to see something similar to that.

Q: Will the trials give information about very rare side effects like the heart inflammation sometimes seen in teens and young adults?

A: We’ll know at least that it’s not ... happening at some much higher rate in younger children. That we can rule out. And we’ll also make sure that there aren’t any other side effects that we haven’t seen in the older age range.

Q: Two of FDA’s top vaccine reviewers recently announced they’re leaving. The agency also is evaluating booster shots for adults. Is that making a child vaccination decision more difficult?

A: I’m not worried that we’re going to suffer any delays because of that. ... We will be parallel processing.

Q: There are reports that some parents are seeking adult vaccines for their kids. What’s your advice?

A: My strongest advice is please don’t do that. Please let us do the evaluation that we need to do to ensure that when you do vaccinate your child, you vaccinate the child with the right dose and in a manner that’s safe.

If you want to do something now for your child, make sure that you’re vaccinated, that your household is vaccinated, that all the people that come in contact with your children are vaccinated and that your child knows how to wear a mask.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 479326

Reported Deaths: 9353
CountyCasesDeaths
Harrison32779484
Hinds30924582
DeSoto30319353
Jackson23542341
Rankin21235366
Lee14803219
Madison14120271
Jones13327223
Forrest13078236
Lauderdale11501303
Lowndes10377176
Lamar10163130
Pearl River9008217
Lafayette8193137
Hancock7404111
Oktibbeha6909122
Washington6900150
Monroe6459159
Neshoba6441201
Warren6387163
Pontotoc623093
Panola6203125
Bolivar6072144
Marshall6068121
Union571386
Pike5574135
Alcorn533289
Lincoln5283131
George466072
Scott454796
Leflore4444140
Prentiss443377
Tippah442180
Itawamba441599
Adams4376116
Tate4327101
Simpson4313112
Wayne430766
Copiah429587
Yazoo419686
Covington413292
Sunflower4123104
Marion4073104
Leake395486
Coahoma391098
Newton367274
Grenada3543104
Stone350359
Tishomingo333288
Attala324286
Jasper313162
Winston303091
Clay294173
Chickasaw286265
Clarke279890
Calhoun263940
Holmes261387
Smith248048
Yalobusha219647
Tallahatchie217550
Walthall209958
Greene206845
Lawrence205732
Perry198553
Amite197651
Webster195042
Noxubee177739
Montgomery171654
Jefferson Davis167442
Carroll161437
Tunica150834
Benton141533
Kemper138039
Claiborne126134
Choctaw126026
Humphreys125937
Franklin116328
Quitman103426
Wilkinson101536
Jefferson87333
Sharkey62320
Issaquena1926
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Alabama Coronavirus Cases

Cases: 778549

Reported Deaths: 13665
CountyCasesDeaths
Jefferson1105871747
Mobile704651206
Madison49152610
Baldwin35946479
Shelby35796302
Tuscaloosa33410532
Montgomery32906672
Lee22231216
Calhoun20791397
Morgan19605326
Etowah18837449
Marshall17465272
Houston16452368
St. Clair15233293
Limestone14376182
Cullman14348246
Elmore14241256
Lauderdale13298278
Talladega12699230
DeKalb12036233
Walker10430323
Autauga9568133
Blount9555152
Jackson9235146
Coffee8728169
Colbert8426179
Dale8410170
Escambia6526114
Tallapoosa6501172
Covington6396163
Chilton6293141
Russell598555
Franklin5719100
Chambers5315133
Marion4734115
Dallas4665182
Clarke457076
Pike456294
Geneva4315116
Winston417192
Lawrence4086108
Bibb401680
Barbour341968
Marengo323183
Butler314988
Monroe314652
Pickens300470
Randolph299955
Henry298356
Hale289383
Cherokee284652
Fayette275672
Washington244848
Crenshaw235168
Clay225163
Macon217657
Cleburne217149
Lamar192140
Conecuh179646
Lowndes170158
Coosa166432
Wilcox155736
Bullock147742
Perry136036
Sumter124136
Greene120142
Choctaw72826
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